Seeking Tysabri trial patients

A board to discuss the newly-released drug Tysabri, (formerly known as Antegren) as a treatment for Multiple Sclerosis

Seeking Tysabri trial patients

Postby jcvm » Wed Mar 02, 2005 7:44 am

Hello everyone,

My name is John Mulligan, a journalist with the Sunday Tribune newspaper in Dublin. I'm writing a piece for this Sunday on Tysabri and am hoping to speak to someone who may have been involved in trials, or who was receiving the treatment prior to its withdrawl. I'd like to chat to you about how effective the treatment was for you, and your thoughts on it being pulled.

I realise for many of you this is an anxious time, but would greatly appreciate getting to speak to someone who would be willing to be identified in an article, perhaps even just by their first name if necessary.

I spoke yesterday to a physician who is a director of a center where some of the initial Natalizumab trials took place and it would be nice to be able to get a patient view too. My email address is

You can email me, or whatever, and I can telephone you for a quick chat.

Looking forward to hearing from you,

Kind regards,

John Mulligan
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Postby mjk » Fri May 13, 2005 8:14 am

where did they take place out of curosity
who were the physicians that handled these tests
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I'm just not sure anymore Mr. Mulligan.

Postby TheTysabriBull » Mon Aug 15, 2005 1:50 pm

I am one of many MSers who may have responded to your request at the beginning of this thread.

After I wrote you a reply to this request, you sent me an reply stating you were no longer interested in any further testimonials from actual patients who had taken Tysabri earlier this year. I was very surprised to hear of that because I was most likely in the first 500 MS patients to get a commercial infusion of this wonderful new drug for MS. Not only did I get one infusion, I got one more within 4 weeks of the suspension.

Since you weren't interested in what Tysabri may have done for me as an MSer I'm going to leave you with a very minor and simple request.

What was the purpose of this article you wrote in this past Sunday's Tribune for August 14th, 2005?

Reference: Ireland's Sunday Tribune, August 14th, 2005

Irish Sunday Tribune, Business section, front page

Fresh fears over Elan Drug
By John Mulligan

The US FDA is closely monitoring the condition of a US patient who took Elan's Tysabri drug and is now displaying some of the indicators of the rare and potentially fatal brain disease, PML. PML has so far killed two patients who were involved in trials of the Tysabri drug which was used to treat multiple sclerosis. The FDA has contacted a 55 year old woman in Indiana a number of times in the past five months for further updates on her condition. The patient, who was diagnosed with MS in 1993, was taking Avonex in the 1990s. The woman is believed to have been prescribed steroids late last year and received a Tysabri infusion at the end of February. She began to feel unwell, but such a side-effect can be expected immediately following a Tysabri infusion. However her condition has rapidly worsened since the beginning of March. A close relative told the Tribune last week that the woman saw a neurologist last Tuesday for further tests, the same day Biogen and Elan announced that there had been no new confirmed cases of PML among the safety review of the 2000 patients taking part in trials.
The Indiana woman has developed several lesions on her brain since March. A scan last September revealed none. She is also understood to have lost her sight in one eye. The FDA first contacted the woman in March and the agency is continuing to closely monitor her status. Elan and Biogen ceased trial and suspended sales of Tysabri at the end of Feb when it emerged that a patient taking the drug for two years whilst also taking Avonex died of PML. A second patient was soon after diagnosed with the disease. A second death occurred in a patient who had been taking Tysabri to treat Crohn’s. However, that person had been misdiagnosed during treatment and had been taking additional drugs that may have served to promote PML. The third diagnosed patient is still alive In June, the FDA confirmed it was investigating an additional possible case. Tysabri had been expected to contribute a much as 3bn dollars in annual sales to Elan and Biogen. Elan would not comment on the latest possible case. "We will not comment on individual cases, or possible cases (of PML)" as spokeswoman said. "The review of MS clinical trial patients and any reports of potential PML in patients receiving Tysabri in the commercial setting to date showed no new confirmed cases", she said.
The spokeswoman said that 91% of clinical patients participated in the safety evaluation process. "The evaluation is ongoing with Crohn's and the RA expected to be completed by the end of summer", she added.
An FDA spokeswoman said it is not the standard practice to contact patients directly and added that she was unaware of this particular case.

Are you the one and the same John Mulligan who wrote the news piece above for this past Sunday's Tribune Aug 14th, 2005?
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Re: I'm just not sure anymore Mr. Mulligan.

Postby DenverCO » Tue Aug 16, 2005 7:32 am

TheTysabriBull wrote:Not only did I get one infusion, I got one more within 4 weeks of the suspension.

You got another infusion after the suspension of before?
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Suspension was on 02/28/05. Tysabri will be back, I hope.

Postby TheTysabriBull » Tue Aug 16, 2005 11:24 am

Howdy Denver,

My first infusion was on Jan 5th. My second infusion was on Feb 4th. Feb 4th was less than 4 weeks from the sudden suspension. My 3rd infusion was scheduled for March 2nd.

The first two infusions were just barely enough to notice some welcome changes within the first 8 weeks of therapy. I had also carefully planned my own Tysabri therapy by intentionally QUITTING Betaseron almost 6 weeks prior to my first infusion. I had been on Betaseron since early '95 and only one month of Avonex in '97. Heh, my liver got a break from the ferons and I got to really feel what the Tysabri might do all by itself, just like the AFFIRM clinical trial patients experienced. I had started getting a new exacerbation about a year ago, severe abdominal muscle spasticity. The spasticity drifted away around week 8. It came back again in early April so I took some baclofen for several days to calm that painful spasm down. Been doing ok since I've actually been off interferon for several months now. I have actually felt a little better these past few months since quitting the interferon at the risk of possible stronger relapse. I am seriously looking forward to getting back on the big T right away. It's a great feeling knowing that there is a new drug that might actually work for so many of us after all these years of torture. And the greater feeling is also knowing I'm not alone. I've been in touch with several MSers who have experienced Tysabri and all of them want it back tomorrow! We all already know that this new drug works too well and will have to take it as a standalone therapy to avoid any synergy with other immune suppressing drugs. As a long time MSer I have found I get some of my best information, support, and advice from my senior fellow patients and those with actual experience with all these drugs.

I'll venture out on a limb here and say most MSers here don't even know that good ole prednisone and IVIG have previously been linked to progressive multi-focal leukoencephalopathy (PML). The docs won't tell us these things because they don't want to scare anybody BECAUSE of this benign JCV virus that most of us spread and carry around with us anyway. It's the concomitant immune-suppressing drugs OUR own doctors COULD aggressively prescribe to us that we should be afraid of!!! The risk of an MSer acquiring or developing PML from standalone Tysabri monotherapy is very close to nil. At least that's what I heard one of the leading infectious disease experts in the world, Dr. Igor Koralnik had said about this unexpected, bizarre, and very rare occurrence in our MSer's tiny little world. If you carefully analyze all the details of the PML occurrences in the Sentinel trial, odds favor that at least one MSer in the past has died from PML long before Tysabri came along. The early presentation of the disease is just too eerily similar to MS. Tunnel vision for a seasoned, practicing MS specialist or neurologist may have led the most experienced MS specialist to mistakenly diagnose this once unheard of disease PML as a progressive form of MS. The Crohn's patient who died back in 2003 also lends credence to the actual cause of these rare but unfortunate occurrences and cascade of events. I am not a doctor or a specialist so please take all of this FWIW as my humble opinion.

Anyhow, I still plan on being one of the first 500 commercial patients to receive Tysabri as soon as it is available.

Sincere regards and best wishes
21+ year Veteran MSer, 10 Year ABCR junkie, and one lucky guy who is experiencing the magical wonders of Tysabri for MS. I maybe totally blind in one eye but, I can sure see straighter out of the other.
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Postby DenverCO » Tue Aug 16, 2005 11:53 am


I did 2 infusions of Tysabri too. I actually went outside of my HMO and privately paid for #1 because Kaiser hadn't added it to their formulary yet. The neurologist who provided #1 didn't have an infusion setup yet (I was the 3rd or 4th person in Colorado to get it), so he had a nursing agency come in and administer it.

I noticed improvement and, like you, I can't wait for the re-introduction.

I'm getting ready to do my second Novantrone treatment the first week in September. They will probably require that I wait 2-3 months after that before I can do Tysabri. I think it's going to get the go ahead in Oct. / Nov. of this year, so that's perfect timing.

Best of luck and good health to us all!
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